As the new year approaches, companies conducting clinical trials in China may want to consider a new regulation that will become effective in March 2024.  On November 3, 2023, China’s National Medical Products Administration (“NMPA”) issued a Guideline on Inspection of Drug Clinical Trial Institutions Conducting Studies (Trial Implementation) (“Inspection Guideline” or “Guideline”).  The Guideline goes into effect on March 1, 2024.

The Inspection Guideline provides information about procedures for inspections of drug clinical trial institutions (i.e., hospitals and clinics) by national and provincial medical products administrations (“MPAs”) under the authority of the Drug Clinical Trial Institution Regulation, Articles 18-23.  A drug clinical trial institution is an institution that has the relevant conditions to support a clinical trial, and complies with Good Clinical Practice for drug clinical trials (“Drug GCP”) and other relevant technical guidelines for conducting drug clinical trials.  The Inspection Guideline clarifies the following:

  • When are inspections conducted?  The Guideline divides inspections into three categories: (1) routine inspections; (2) for-cause inspections; and (3) other inspections, including special inspections.  Routine inspections are conducted according to a risk-based annual plan that each provincial MPA establishes.  For-cause inspections, by contrast, are triggered when an MPA believes that a drug clinical trial institution may have quality issues, or when an MPA receives complaints about potential violations.  MPAs can increase the frequency of inspection of a drug clinical trial institution, if (1) the institution has had serious compliance issues in the past; (2) the clinical investigation team has issues that may affect study quality, including the investigator conducting too many studies at the same time, lack of management skills of the investigator, and insufficient staff on the investigation team; and/or (3) the MPA receives complaints or other indications that the institution has quality problems.
  • What happens during a routine inspection?  Inspections are primarily on-site, although remote inspections remain an option for MPAs.  MPAs should notify the institution five to seven days in advance of a routine inspection.  Upon arrival, the MPA inspection team issues a notice of inspection, sets out the scope of the inspection, and explains the rights and responsibilities of the institution.  The Drug GCP promulgated in 2020 provides that during inspections, inspectors can access “source data,” “source documents,” and medical records of subjects.
  • How is a for-cause inspection conducted differently from a routine inspection?  An MPA does not need to notify the institution in advance of a for-cause inspection.  Additionally, upon arrival, the inspection team does not need to conduct a meeting with institution staff.  By contrast, during a routine inspection, the inspection team would issue the inspection notice, and explain the scope of investigation and the institution’s rights and responsibilities.
  • What happens following an inspection?  At the end of an inspection, the inspection team should conduct an exit interview, where the inspectors discuss the findings from the inspection.  If the institution disagrees with the findings, the institution has an opportunity to respond.  The inspection team must then issue a written list of deficiencies.  The institution must take corrective actions in response to these deficiencies and submit a corrective action report within 20 business days after the inspection.

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Contributors for the China & APAC Food, Drug, Device, and Cosmetics blog:

John Balzano, Julia Post, Muyun Hu, Annie Wang, Kaixin Fan, and Kexin Yang.

Photo of Kaixin Fan Kaixin Fan

Kaixin Fan is an associate in the firm’s London office, where she is a member of the Dispute Resolution Practice Group. Prior to joining the London office, Kaixin was resident in the firm’s San Francisco office, where she was a member of the…

Kaixin Fan is an associate in the firm’s London office, where she is a member of the Dispute Resolution Practice Group. Prior to joining the London office, Kaixin was resident in the firm’s San Francisco office, where she was a member of the Food, Drug, and Device and the Litigation and Investigations Practice Groups. Kaixin also maintains an active pro bono practice.

Photo of John Balzano John Balzano

John Balzano represents companies and business associations on U.S. and China regulatory and policy matters related to food, drugs, medical devices, cosmetics, and other regulated products.

John has over a decade of experience with legal and regulatory issues related to China, particularly with…

John Balzano represents companies and business associations on U.S. and China regulatory and policy matters related to food, drugs, medical devices, cosmetics, and other regulated products.

John has over a decade of experience with legal and regulatory issues related to China, particularly with regard to products regulated by the State Administration for Market Regulation, the National Medical Products Administration (NMPA), and other agriculture, animal and healthcare (including digital health) products and services. He assists clients with developing strategies to obtain pre-market approvals for these products in China, including clinical development, understanding relevant pricing and reimbursement policies, and reviewing distribution and promotional plans.

He also advises on regulatory compliance, due diligence, and enforcement matters for China operations, including drafting and revising and integrating China and global standard operating procedures, assessing the functions of regulatory departments in China, responding to inspection results and enforcement inquiries, and implementing product recalls. John also has significant experience designing strategies to handle professional consumer litigation for food and cosmetic companies operating in China and working with local counsel.

He advises companies and industry associations on their advocacy strategies, including the notice and comment process before NMPA and other regulatory agencies.

John has particular experience in the U.S. advising on the requirements for the acquisition and transfer of biospecimens for research purposes.